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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 42 - Public Health |
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Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
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SubChapter G - Standards and Certification |
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Part 493 - Laboratory Requirements |
| Subpart A - General Provisions |
| § 493.1 - Basis and scope. |
| § 493.2 - Definitions. |
| § 493.3 - Applicability. |
| § 493.5 - Categories of tests by complexity. |
| § 493.15 - Laboratories performing waived tests. |
| § 493.17 - Test categorization. |
| § 493.19 - Provider-performed microscopy (PPM) procedures. |
| § 493.20 - Laboratories performing tests of moderate complexity. |
| § 493.25 - Laboratories performing tests of high complexity. |
| Subpart B - Certificate of Waiver |
| § 493.35 - Application for a certificate of waiver. |
| § 493.37 - Requirements for a certificate of waiver. |
| § 493.39 - Notification requirements for laboratories issued a certificate of waiver. |
| § 493.41 - Condition: Reporting of SARS-CoV-2 test results. |
| Subpart C - Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance |
| § 493.43 - Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance. |
| § 493.45 - Requirements for a registration certificate. |
| § 493.47 - Requirements for a certificate for provider-performed microscopy (PPM) procedures. |
| § 493.49 - Requirements for a certificate of compliance. |
| § 493.51 - Notification requirements for laboratories issued a certificate of compliance. |
| § 493.53 - Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures. |
| Subpart D - Certificate of Accreditation |
| § 493.55 - Application for registration certificate and certificate of accreditation. |
| § 493.57 - Requirements for a registration certificate. |
| § 493.61 - Requirements for a certificate of accreditation. |
| § 493.63 - Notification requirements for laboratories issued a certificate of accreditation. |
| Subpart E - Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program |
| § 493.551 - General requirements for laboratories. |
| § 493.553 - Approval process (application and reapplication) for accreditation organizations and State licensure programs. |
| § 493.555 - Federal review of laboratory requirements. |
| § 493.557 - Additional submission requirements. |
| § 493.559 - Publication of approval of deeming authority or CLIA exemption. |
| § 493.561 - Denial of application or reapplication. |
| § 493.563 - Validation inspections - Basis and focus. |
| § 493.565 - Selection for validation inspection - laboratory responsibilities. |
| § 493.567 - Refusal to cooperate with validation inspection. |
| § 493.569 - Consequences of a finding of noncompliance as a result of a validation inspection. |
| § 493.571 - Disclosure of accreditation, State and CMS validation inspection results. |
| § 493.573 - Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs. |
| § 493.575 - Removal of deeming authority or CLIA exemption and final determination review. |
| Subpart F - General Administration |
| § 493.602 - Scope of subpart. |
| § 493.606 - Applicability of subpart. |
| § 493.638 - Certificate fees. |
| § 493.639 - Fees for revised and replacement certificates. |
| § 493.643 - Additional fees applicable to laboratories issued a certificate of compliance. |
| § 493.645 - Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures. |
| § 493.646 - Payment of fees. |
| § 493.649 - Additional fees applicable to approved State laboratory programs. |
| § 493.655 - Payment of fees. |
| § 493.680 - Methodology for determining the biennial fee increase. |
| Subpart G - XXX |
| Subpart H - Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing |
| § 493.801 - Condition: Enrollment and testing of samples. |
| § 493.803 - Condition: Successful participation. |
| § 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing. |
| Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests |
| § 493.821 - Condition: Microbiology. |
| § 493.823 - Standard; Bacteriology. |
| § 493.825 - Standard; Mycobacteriology. |
| § 493.827 - Standard; Mycology. |
| § 493.829 - Standard; Parasitology. |
| § 493.831 - Standard; Virology. |
| § 493.833 - Condition: Diagnostic immunology. |
| § 493.835 - Standard; Syphilis serology. |
| § 493.837 - Standard; General immunology. |
| § 493.839 - Condition: Chemistry. |
| § 493.841 - Standard; Routine chemistry. |
| § 493.843 - Standard; Endocrinology. |
| § 493.845 - Standard; Toxicology. |
| § 493.849 - Condition: Hematology. |
| § 493.851 - Standard; Hematology. |
| § 493.853 - Condition: Pathology. |
| § 493.855 - Standard; Cytology: gynecologic examinations. |
| § 493.857 - Condition: Immunohematology. |
| § 493.859 - Standard; ABO group and D (Rho) typing. |
| § 493.861 - Standard; Unexpected antibody detection. |
| § 493.863 - Standard; Compatibility testing. |
| § 493.865 - Standard; Antibody identification. |
| Subpart I - Proficiency Testing Programs for Nonwaived Testing |
| § 493.901 - Approval of proficiency testing programs. |
| § 493.903 - Administrative responsibilities. |
| § 493.905 - Nonapproved proficiency testing programs. |
| Proficiency Testing Programs by Specialty and Subspecialty |
| § 493.909 - Microbiology. |
| § 493.911 - Bacteriology. |
| § 493.913 - Mycobacteriology. |
| § 493.915 - Mycology. |
| § 493.917 - Parasitology. |
| § 493.919 - Virology. |
| § 493.921 - Diagnostic immunology. |
| § 493.923 - Syphilis serology. |
| § 493.927 - General immunology. |
| § 493.929 - Chemistry. |
| § 493.931 - Routine chemistry. |
| § 493.933 - Endocrinology. |
| § 493.937 - Toxicology. |
| § 493.941 - Hematology (including routine hematology and coagulation). |
| § 493.945 - Cytology; gynecologic examinations. |
| § 493.959 - Immunohematology. |
| Subpart J - Facility Administration for Nonwaived Testing |
| § 493.1100 - Condition: Facility administration. |
| § 493.1101 - Standard: Facilities. |
| § 493.1103 - Standard: Requirements for transfusion services. |
| § 493.1105 - Standard: Retention requirements. |
| § 493.1107 - Standard; Test records. |
| § 493.1109 - Standard; Test report. |
| § 493.1111 - Standard; Referral of specimens. |
| Subpart K - Quality System for Nonwaived Testing |
| § 493.1200 - Introduction. |
| § 493.1201 - Condition: Bacteriology. |
| § 493.1202 - Condition: Mycobacteriology. |
| § 493.1203 - Condition: Mycology. |
| § 493.1204 - Condition: Parasitology. |
| § 493.1205 - Condition: Virology. |
| § 493.1207 - Condition: Syphilis serology. |
| § 493.1208 - Condition: General immunology. |
| § 493.1210 - Condition: Routine chemistry. |
| § 493.1211 - Condition: Urinalysis. |
| § 493.1212 - Condition: Endocrinology. |
| § 493.1213 - Condition: Toxicology. |
| § 493.1215 - Condition: Hematology. |
| § 493.1217 - Condition: Immunohematology. |
| § 493.1218 - Standard; Control procedures. |
| § 493.1219 - Condition: Histopathology. |
| § 493.1220 - Condition: Oral pathology. |
| § 493.1221 - Condition: Cytology. |
| § 493.1223 - Condition: Quality control—specialties and subspecialties for tests of moderate or high complexity, or both. |
| § 493.1225 - Condition: Clinical cytogenetics. |
| § 493.1226 - Condition: Radiobioassay. |
| § 493.1227 - Condition: Histocompatibility. |
| § 493.1229 - Condition: Mycobacteriology. |
| § 493.1237 - Condition: Diagnostic immunology. |
| § 493.1243 - Condition: Chemistry. |
| § 493.1245 - Condition: Routine chemistry. |
| § 493.1247 - Condition: Endocrinology. |
| § 493.1257 - Condition: Cytology. |
| § 493.1259 - Condition: Histopathology. |
| § 493.1275 - Standard; Blood and blood products storage facilities. |
| § 493.1277 - Standard; Arrangement for services. |
| § 493.1279 - Standard; Provision of testing. |
| § 493.1285 - Standard; Investigation of transfusion reactions. |
| Postanalytic Systems |
| § 493.1290 - Condition: Postanalytic systems. |
| § 493.1291 - Standard: Test report. |
| § 493.1299 - Standard: Postanalytic systems quality assessment. |
| General Laboratory Systems |
| § 493.1230 - Condition: General laboratory systems. |
| § 493.1231 - Standard: Confidentiality of patient information. |
| § 493.1232 - Standard: Specimen identification and integrity. |
| § 493.1233 - Standard: Complaint investigations. |
| § 493.1234 - Standard: Communications. |
| § 493.1235 - Standard: Personnel competency assessment policies. |
| § 493.1236 - Standard: Evaluation of proficiency testing performance. |
| § 493.1239 - Standard: General laboratory systems quality assessment. |
| Analytic Systems |
| § 493.1250 - Condition: Analytic systems. |
| § 493.1251 - Standard: Procedure manual. |
| § 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies. |
| § 493.1253 - Standard: Establishment and verification of performance specifications. |
| § 493.1254 - Standard: Maintenance and function checks. |
| § 493.1255 - Standard: Calibration and calibration verification procedures. |
| § 493.1256 - Standard: Control procedures. |
| § 493.1261 - Standard: Bacteriology. |
| § 493.1262 - Standard: Mycobacteriology. |
| § 493.1263 - Standard: Mycology. |
| § 493.1264 - Standard: Parasitology. |
| § 493.1265 - Standard: Virology. |
| § 493.1267 - Standard: Routine chemistry. |
| § 493.1269 - Standard: Hematology. |
| § 493.1271 - Standard: Immunohematology. |
| § 493.1273 - Standard: Histopathology. |
| § 493.1274 - Standard: Cytology. |
| § 493.1276 - Standard: Clinical cytogenetics. |
| § 493.1278 - Standard: Histocompatibility. |
| § 493.1281 - Standard: Comparison of test results. |
| § 493.1282 - Standard: Corrective actions. |
| § 493.1283 - Standard: Test records. |
| § 493.1289 - Standard: Analytic systems quality assessment. |
| Preanalytic Systems |
| § 493.1240 - Condition: Preanalytic systems. |
| § 493.1241 - Standard: Test request. |
| § 493.1242 - Standard: Specimen submission, handling, and referral. |
| § 493.1249 - Standard: Preanalytic systems quality assessment. |
| Subpart L - XXX |
| Subpart M - Personnel for Nonwaived Testing |
| § 493.1351 - General. |
| Laboratories Performing Moderate Complexity Testing |
| § 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director. |
| § 493.1405 - Standard; Laboratory director qualifications. |
| § 493.1406 - Standard; Laboratory director qualifications on or before February 28, 1992. |
| § 493.1407 - Standard; Laboratory director responsibilities. |
| § 493.1409 - Condition: Laboratories performing moderate complexity testing; technical consultant. |
| § 493.1411 - Standard; Technical consultant qualifications. |
| § 493.1413 - Standard; Technical consultant responsibilities. |
| § 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant. |
| § 493.1417 - Standard; Clinical consultant qualifications. |
| § 493.1419 - Standard; Clinical consultant responsibilities. |
| § 493.1421 - Condition: Laboratories performing moderate complexity testing; testing personnel. |
| § 493.1423 - Standard; Testing personnel qualifications. |
| § 493.1425 - Standard; Testing personnel responsibilities. |
| Laboratories Performing High Complexity Testing |
| § 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director. |
| § 493.1443 - Standard; Laboratory director qualifications. |
| § 493.1445 - Standard; Laboratory director responsibilities. |
| § 493.1447 - Condition: Laboratories performing high complexity testing; technical supervisor. |
| § 493.1449 - Standard; Technical supervisor qualifications. |
| § 493.1451 - Standard: Technical supervisor responsibilities. |
| § 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant. |
| § 493.1455 - Standard; Clinical consultant qualifications. |
| § 493.1457 - Standard; Clinical consultant responsibilities. |
| § 493.1459 - Condition: Laboratories performing high complexity testing; general supervisor. |
| § 493.1461 - Standard: General supervisor qualifications. |
| § 493.1462 - General supervisor qualifications on or before February 28, 1992. |
| § 493.1463 - Standard: General supervisor responsibilities. |
| § 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor. |
| § 493.1469 - Standard: Cytology general supervisor qualifications. |
| § 493.1471 - Standard: Cytology general supervisor responsibilities. |
| § 493.1481 - Condition: Laboratories performing high complexity testing; cytotechnologist. |
| § 493.1483 - Standard: Cytotechnologist qualifications. |
| § 493.1485 - Standard; Cytotechnologist responsibilities. |
| § 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel. |
| § 493.1489 - Standard; Testing personnel qualifications. |
| § 493.1491 - Technologist qualifications on or before February 28, 1992. |
| § 493.1495 - Standard; Testing personnel responsibilities. |
| Laboratories Performing Provider-Performed Microscopy (Ppm) Procedures |
| § 493.1353 - Scope. |
| § 493.1355 - Condition: Laboratories performing PPM procedures; laboratory director. |
| § 493.1357 - Standard; laboratory director qualifications. |
| § 493.1359 - Standard; PPM laboratory director responsibilities. |
| § 493.1361 - Condition: Laboratories performing PPM procedures; testing personnel. |
| § 493.1363 - Standard: PPM testing personnel qualifications. |
| § 493.1365 - Standard; PPM testing personnel responsibilities. |
| Subparts N--P - XXX |
| Subpart P - Quality Assurance for Moderate Complexity (Including the Subcategory) or High Complexity Testing, or Any Combination of These Tests |
| § 493.1701 - Condition: Quality assurance; moderate complexity (including the subcategory) or high complexity testing, or any combination of these tests. |
| § 493.1703 - Standard; Patient test management assessment. |
| § 493.1705 - Standard; Quality control assessment. |
| § 493.1707 - Standard; Proficiency testing assessment. |
| § 493.1709 - Standard; Comparison of test results. |
| § 493.1711 - Standard; Relationship of patient information to patient test results. |
| § 493.1713 - Standard; Personnel assessment. |
| § 493.1715 - Standard; Communications. |
| § 493.1717 - Standard; Complaint investigations. |
| § 493.1719 - Standard; Quality assurance review with staff. |
| § 493.1721 - Standard; Quality assurance records. |
| Subpart Q - Inspection |
| § 493.1771 - Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories. |
| § 493.1773 - Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories. |
| § 493.1775 - Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures. |
| § 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance. |
| § 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation. |
| Subpart R - Enforcement Procedures |
| § 493.1800 - Basis and scope. |
| § 493.1804 - General considerations. |
| § 493.1806 - Available sanctions: All laboratories. |
| § 493.1807 - Additional sanctions: Laboratories that participate in Medicare. |
| § 493.1808 - Adverse action on any type of CLIA certificate: Effect on Medicare approval. |
| § 493.1809 - Limitation on Medicaid payment. |
| § 493.1810 - Imposition and lifting of alternative sanctions. |
| § 493.1812 - Action when deficiencies pose immediate jeopardy. |
| § 493.1814 - Action when deficiencies are at the condition level but do not pose immediate jeopardy. |
| § 493.1816 - Action when deficiencies are not at the condition level. |
| § 493.1820 - Ensuring timely correction of deficiencies. |
| § 493.1826 - Suspension of part of Medicare payments. |
| § 493.1828 - Suspension of all Medicare payments. |
| § 493.1832 - Directed plan of correction and directed portion of a plan of correction. |
| § 493.1834 - Civil money penalty. |
| § 493.1836 - State onsite monitoring. |
| § 493.1838 - Training and technical assistance for unsuccessful participation in proficiency testing. |
| § 493.1840 - Suspension, limitation, or revocation of any type of CLIA certificate. |
| § 493.1842 - Cancellation of Medicare approval. |
| § 493.1844 - Appeals procedures. |
| § 493.1846 - Civil action. |
| § 493.1850 - Laboratory registry. |
| Subpart S - XXX |
| Subpart T - Consultations |
| § 493.2001 - Establishment and function of the Clinical Laboratory Improvement Advisory Committee. |